Declaration of Conformity and Essential Requirements in Morocco

1. Key takeaways

Article 5 of Law No. 84-12 sets two layers of obligation. Devices must present a high level of safety in use for patients, professionals, and third parties, and must conform to the essential requirements of quality, safety, and performance fixed by regulation. In addition, every device must be accompanied by instructions for use or a label containing the information necessary for safe use and allowing the manufacturer to be identified. Morocco requires the declaration of conformity with the essential requirements to be issued by the establishment, and that declaration must be dated, signed, and stamped by the legal representative.

The consequence of the first layer is that conformity work in Morocco is a checklist exercise, not a statement of intent. The essential requirements are fixed by a regulatory text, Arrêté n° 2856-15, which structures them after the essential requirements system of the European Union medical device directives. A conformity mapping built against that order, item by item, is the document reviewers expect; a general assertion of conformity is not.

The consequence of the second layer is that conformity in Morocco is locally endorsed. Unlike the European Union system, where the manufacturer issues the declaration of conformity, Morocco requires the Moroccan establishment to stand behind conformity with its own signature. This makes the establishment a compliance partner from the earliest stage of the project, not merely a filing channel.

2. Legal basis

3. Expert insights

Insight one: the content of the essential requirements is not in Article 5 but in the order. Article 5 only states that the requirements are fixed by regulation (fixées par voie réglementaire). The concretization is carried by Arrêté n° 2856-15, whose structure follows the essential requirements system of the European Union medical device directives. When performing a conformity mapping, companies should work against the order rather than against Article 5 itself, because the order is where each requirement is actually stated and can be checked.

Insight two: the issuer of the declaration of conformity is the establishment, which is Morocco’s particular feature. Article 3 of Arrêté n° 2855-15 places the declaration of conformity made by the establishment regarding the conformity of the device with the essential requirements alongside all the administrative documents, and requires it to be signed by the legal representative of the Moroccan establishment. This differs from the European Union practice in which the manufacturer issues the EU declaration of conformity: Morocco requires a local entity to endorse conformity with its own signature, which allocates real responsibility inside Morocco rather than leaving it entirely abroad.

Insight three: conformity is one of the three objectives of clinical evaluation under Article 15. Article 15, second paragraph, item 3 requires that clinical investigations or the evaluation of clinical data confirm that the device conforms with the essential requirements referred to in Article 5. This ties the declaration of conformity to clinical evidence: the declaration is not an isolated self-declaration but needs evidentiary support under Article 15. A conformity table that cites the corresponding clinical evaluation conclusion for each relevant requirement is therefore stronger than one that cites only bench data.

Insight four: the identifiability of the manufacturer under the second paragraph of Article 5 is a low threshold checked frequently. The provision requires the instructions or the label to allow the manufacturer to be identified. The common failure in practice is a label that shows only the trademark, or only the local distributor’s name, without the manufacturer’s name and address. The fix costs nothing at the artwork stage and is far cheaper than a label reprint after review.

Insight five: the high level of safety in the first paragraph of Article 5 is a principle that leaves room for discretion. Unlike the essential requirements, which can be checked item by item, a high level of safety in use is an open standard, and the competent authority can invoke it when assessing risk under Article 26. Companies should not treat conformity mapping as exhausting their safety argument; the dossier should also show, in narrative form, that the device presents a high level of safety for patients, professionals, and third parties.

4. Practical recommendations

1. Build an item-by-item conformity table against Arrêté n° 2856-15. For each essential requirement, record three columns: applicable or not applicable with reasons, the manner in which conformity is achieved, and the source of the evidence. The reasons column matters as much as the rest, because unsupported exclusions invite questions.
2. Have the declaration of conformity issued by the licensed establishment. Confirm the declaration template, the signatory, and the signature workflow with the establishment early, so the document is ready when the rest of the dossier is.
3. Link clinical evidence into the conformity table. Conclusions obtained under Article 15 should be cited in the conformity table as the corresponding evidence, so the declaration and the clinical file reinforce each other.
4. Check the identifiability of the manufacturer on the label. Confirm that both the label and the instructions for use state the manufacturer’s name and address, not only distributor information.
5. Keep the declaration synchronized with the fiche signalétique. The models and class stated on the declaration of conformity must match the fiche signalétique and the CE certificate, field for field.

5. Verification checklist

• □ Essential requirements list obtained under Arrêté n° 2856-15
• □ Conformity table completed item by item with applicability and manner of conformity
• □ Reasons stated for every non-applicable requirement
• □ Declaration of conformity dated, signed, and stamped by the legal representative of the Moroccan establishment
• □ Clinical evaluation conclusions under Article 15 cited as conformity evidence
• □ Label and instructions for use state the manufacturer’s name and address
• □ Models and class on the declaration consistent with the fiche signalétique and the CE certificate

GRZAN supports manufacturers and Moroccan establishments with declarations of conformity and essential requirements mapping for the Moroccan market, including item-by-item tables against Arrêté n° 2856-15, declaration workflow coordination with the licensed establishment, and cross-document consistency checks. For assistance with registration documentation and conformity files for Morocco, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026